BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC

    MDR report key: 7778554 · Received August 13, 2018

    Report

    Report Number
    3005670412-2018-00007
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 4, 2018
    Report Date
    July 18, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HRS
    UDI-DI
    10814493010104
    PMA / PMN Number
    K051410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED RIB FRACTURES IN 2012. RIBS 6&7 WERE PLATED. RECENTLY PATIENT REACHED DOWN TO PICK UP CHILD, FELT A POP AND PAIN IN LEFT RIB CASE. X-RAYS SHOW ORIGINAL FRACTURE TO HAVE HEALED. BROKEN PLATE AND ASSOCIATED SCREWS WERE REMOVED. PARTS WERE RETURNED FOR INVESTIGATION, NO OBVIOUS FAILURE MODE WAS IDENTIFIED. NORMAL WEAR FROM INSTALLATION AND REMOVAL WERE NOTED ON THE SCREWS. BROKEN PLATE ENDS WERE RUBBED SMOOTH FROM RUBBING, HOW LONG COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617276 RIBLOC RIBLOC 10MMX76MM RIB PLATE HRS ACUTE INNOVATIONS LLC RBP1132 L1201010 10814493010104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention